Healthcare Industry News: bupivacaine
News Release - February 27, 2008
ZARS Pharma Announces Marketing Authorization of Rapydan(R) in EuropeSALT LAKE CITY, Feb. 27 (HSMN NewsFeed) -- ZARS Pharma, Inc. announced today that Rapydan® (70 mg lidocaine/70 mg tetracaine medicated plaster) has now received marketing authorization in Sweden, the United Kingdom, the Netherlands, France, Spain, Austria, the Czech Republic, Greece, Ireland, Norway and Portugal following the completion of the European Mutual Recognition Procedure. ZARS Pharma has licensed the European sales and marketing rights of Rapydan to EUSA Pharma, Inc. Rapydan received marketing authorization in Sweden in January 2007 and was launched in May 2007. EUSA Pharma began launching Rapydan in other European Union countries in early 2008.
Rapydan is a topical local anesthetic patch approved for use on normal and intact skin to provide surface anesthesia of the skin in connection with needle punctures, in children from 3 years and above, and needle punctures and superficial surgical procedures in adults. Rapydan resembles a small adhesive bandage in appearance and is similar in its ease of application. The patch is applied to the skin for 30 minutes before painful medical procedures. Rapydan is the first product approved in Europe using the patented Controlled Heat-Assisted Drug Delivery or CHADD® technology developed by ZARS Pharma.
Rapydan is marketed as Synera® (lidocaine 70 mg and tetracaine 70 mg) in the United States and was approved by the U.S. Food and Drug Administration in 2005.
Robert Lippert, President and Chief Executive of ZARS Pharma stated, "We are pleased to announce the approval of Rapydan in a number of European Union countries with a uniquely positioned commercial partner. Rapydan is the first anesthetic patch innovation to be approved in over a decade that works faster than the current standard of care and will soon become a best-in-class therapy for patients undergoing painful needle procedures."
Rapydan is comprised of a thin layer of a patented local anesthetic formulation integrated with an oxygen-activated heating component (Controlled Heat-Assisted Drug Delivery system). When removed from the storage pouch, Rapydan begins to heat, warming the skin upon application. The heating component is intended to enhance the delivery of the local anesthetics into the skin and to provide vasodilation.
In clinical trials, the most common side effect was local skin reactions, such as erythema, edema, and blanching. Rapydan should not be used for a longer duration than recommended, and is contraindicated in patients with a known history of sensitivity to lidocaine, tetracaine or local anesthetics of the amide or ester type.
About ZARS Pharma
ZARS Pharma is a specialty pharmaceutical company focused on the development and commercialization of topically administered drugs using proprietary drug delivery technologies, primarily in the area of pain management and dermatology. ZARS Pharma has developed a rich portfolio of proprietary products and product candidates based on the CHADD technology and on cream technologies (Peel and DuraPeel(TM)) that transform, or phase-change, from an initial liquid phase to a solid phase during application. ZARS Pharma's product portfolio includes two products that have been approved for marketing (Pliaglis(TM) and Synera, latter marketed as Rapydan in Europe). ZARS Pharma currently has one product in a late-stage clinical trial that commenced in June 2007 (ThermoProfen(TM)) and four additional products that have entered various stages of clinical development. For more information on ZARS Pharma, please visit http://www.zars.com.
About EUSA Pharma
EUSA Pharma is a rapidly growing transatlantic specialty pharmaceutical company focused on inlicensing, developing and marketing late-stage oncology, pain control and critical care products. The company currently has six products on the market, including the antibiotic surgical implant Collatamp® G, Erwinase® and Kidrolase® for the treatment of acute lymphoblastic leukemia, and Rapydan®, a rapid-onset anesthetic patch. EUSA also has several products in late-stage development, notably Collatamp® G topical, a gentamicin impregnated collagen sponge for the prevention and treatment of infected skin ulcers, and CollaRx® bupivacaine implant for local post-surgical pain control. For more information, please visit http://www.eusapharma.com.
Source: ZARS Pharma
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.